AlloHCT With PegINFa for Myelofibrosis
ConditionMyelofibrosis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah
About this trial
This is a single site, open-label, dose de-escalation, Phase 1 study of pegylated interferon alfa-2a administered after alloHCT in subjects with primary or secondary myelofibrosis. Part 1 of the study will assess the rate of dose-limiting toxicities (DLTs) during the DLT evaluation period and identify the Recommended Phase 2 Dose (RP2D). Once the RP2D is identified, 6 additional patients will be enrolled in the expansion cohort.
Eligibility criteria
Qualifiers
Male or female subject aged ≥ 18 years.
Diagnosis of primary or secondary myelofibrosis.
Eligible to undergo a myeloablative or reduced intensity conditioning regimen (MAC or RIC)
Eligible to undergo a standard of care bone marrow biopsy with aspirate as part of his or her routine pre-transplant work-up.
Disqualifiers
Receiving other investigational agents concurrently
Prior systemic anti-cancer therapy or any investigational therapy within five half-lives prior to starting study treatment.
Prior radiotherapy within 6 weeks prior to the first dose of study treatment.
Major surgery within 6 weeks prior to starting study drug or patients who have not fully recovered from major surgery.
Trial design
Treatments tested in this trial
- Pegylated interferon alpha2a
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Utah
Lead sponsor
Huntsman Cancer Institute
Collaborator
Source ClinicalTrials.gov